Electrodes for intra-cardiac pacemaker

ABSTRACT

A pacemaker has a housing and a therapy delivery circuit enclosed by the housing for generating pacing pulses for delivery to a patient&#39;s heart. An electrically insulative distal member is coupled directly to the housing and at least one non-tissue piercing cathode electrode is coupled directly to the insulative distal member. A tissue piercing electrode extends away from the housing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/130,272, filed Sep. 13, 2018, which claims the benefit of U.S.Provisional Application Ser. No. 62/559,106, filed Sep. 15, 2017, andU.S. Provisional Application Ser. No. 62/583,075, filed Nov. 8, 2017,the entire contents of which are incorporated by reference herein.

TECHNICAL FIELD

The disclosure relates generally to implantable medical devices and inparticular to an intra-cardiac pacemaker.

BACKGROUND

The cardiac conduction system includes the sinus atrial (SA) node, theatrioventricular (AV) node, the bundle of His, bundle branches andPurkinje fibers. A heart beat is initiated in the SA node, which acts asthe natural “pacemaker” of the heart. An electrical impulse arising fromthe SA node causes the atrial myocardium to contract. The signal isconducted to the ventricles via the AV node which inherently delays theconduction to allow the atria to stop contracting before the ventriclesbegin contracting thereby providing proper AV synchrony. The electricalimpulse is conducted from the AV node to the ventricular myocardium viathe bundle of His, bundle branches and Purkinje fibers.

Patients with a conduction system abnormality, e.g., poor AV nodeconduction or poor SA node function, may receive a pacemaker to restorea more normal heart rhythm and atrioventricular synchrony. Dual chamberpacemakers are available which include a transvenous atrial leadcarrying electrodes which are placed in the right atrium and atransvenous ventricular lead carrying electrodes that are placed in theright ventricle via the right atrium The pacemaker itself is generallyimplanted in a subcutaneous pocket with the transvenous leads tunneledto the subcutaneous pocket. A dual chamber pacemaker senses atrialelectrical signals and ventricular electrical signals and can provideboth atrial pacing and ventricular pacing as needed to promote a normalheart rhythm and AV synchrony.

Intracardiac pacemakers have been introduced or proposed forimplantation entirely within a patient's heart, eliminating the need fortransvenous leads which can be a source of infection or othercomplications. An intracardiac pacemaker may provide sensing and pacingwithin a single chamber of the patient's heart. In some patient's singlechamber pacing and sensing may adequately address the patient's needs,however single chamber pacing and sensing may not fully address thecardiac conduction disease or abnormalities in all patients. Dualchamber sensing and/or pacing functions may be required to restore amore normal heart rhythm.

SUMMARY

In general, the disclosure is directed to an intracardiac pacemaker. Theintracardiac pacemaker includes multiple electrodes coupled to aninsulative distal member of the pacemaker housing. In some examples, atleast one non-tissue piercing cathode electrode is coupled directly tothe insulative distal member and a tissue piercing electrode extendsaway from the insulative distal member. The non-tissue piercing cathodeelectrode may be used to sense electrical signals from and deliverelectrical pulses to adjacent cardiac tissue. The tissue piercingelectrode may be used to sense electrical signals from and deliverelectrical pulses to cardiac tissue spaced apart from the adjacentcardiac tissue (i.e., the cardiac tissue adjacent to the non-tissuepiercing cathode electrode).

In one example, the disclosure provides a pacemaker including a housinghaving a proximal end, a distal end and a longitudinal sidewallextending from the proximal end to the distal end and a therapy deliverycircuit enclosed by the housing for generating pacing pulses fordelivery to a patient's heart. The pacemaker includes an anode electrodedefined by an electrically conductive portion of the housing and anelectrically insulative distal member coupled to the housing distal end.At least one non-tissue piercing cathode electrode is coupled directlyto the insulative distal member and electrically coupled to the therapydelivery circuit for delivering a first portion of the generated pacingpulses via a first pacing electrode vector including the at least onenon-tissue piercing cathode electrode and the anode electrode. A tissuepiercing electrode extends away from the housing distal end fordelivering a second portion of the generated pacing pulses.

In another example, the disclosure provides a pacemaker system includinga pacemaker having a housing with a proximal end, a distal end and alongitudinal sidewall extending from the proximal end to the distal end.A therapy delivery circuit is enclosed by the housing for generatingpacing pulses for delivery to a patient's heart. An anode electrode isdefined by an electrically conductive portion of the housing. Anelectrically insulative distal member is coupled to the housing distalend. At least one non-tissue piercing cathode electrode is coupleddirectly to the insulative distal member and electrically coupled to thetherapy delivery circuit for delivering at least a portion of thegenerated pacing pulses via a pacing electrode vector including the atleast one non-tissue piercing cathode electrode and the anode electrode.A tissue piercing electrode includes an electrically insulated shaftextending from a distal shaft end to a proximal shaft end that iscoupled to the housing distal end and a tip electrode at the distalshaft end. The pacemaker further includes a delivery tool interfacemember extending from the housing proximal end for receiving a deliverytool for advancing the tip electrode into a first heart chamber tissuefor pacing a first heart chamber and advancing the at least onenon-tissue piercing cathode along a second heart chamber tissue forpacing a second heart chamber.

In another example, the disclosure provides a method performed by apacemaker having a housing enclosing a therapy delivery circuit forgenerating a plurality of pacing pulses. The method includes deliveringa first portion of the pacing pulses via at least one non-tissuepiercing cathode electrode directly coupled to an insulative distalmember coupled to a distal end of the housing to pace a first heartchamber and delivering a second portion of the pacing pulses via atissue-piercing distal electrode having a cathode tip electrodeextending away from the housing distal end to pace a second heartchamber different than the first heart chamber.

This summary is intended to provide an overview of the subject matterdescribed in this disclosure. It is not intended to provide an exclusiveor exhaustive explanation of the apparatus and methods described indetail within the accompanying drawings and description below. Furtherdetails of one or more examples are set forth in the accompanyingdrawings and the description below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a conceptual diagram of a dual chamber intracardiac pacemakerimplanted in a patient's heart.

FIG. 2 is an enlarged conceptual diagram of a dual chamber intracardiacpacemaker and anatomical structures of the patient's heart according toone example.

FIG. 3 is a perspective view of a dual chamber intracardiac pacemakerhaving a distal fixation and electrode assembly that includes a distalhousing-based electrode implemented as a ring electrode.

FIG. 4 is a perspective view of dual chamber intracardiac pacemakeraccording to another example.

FIG. 5 is a perspective view of dual chamber intracardiac pacemakeraccording to another example.

FIG. 6 is a sectional view of a distal portion of the dual chamberintracardiac pacemaker of FIG. 5.

FIG. 7 is a perspective view of an intracardiac pacemaker according toyet another example.

FIG. 8 is a perspective view of a dual chamber intracardiac pacemakerhaving a second electrode carried by the dart electrode according toanother example.

FIG. 9 is a conceptual diagram of the dual chamber intracardiacpacemaker of FIG. 5 loaded in a delivery tool.

FIG. 10 is a conceptual diagram of an intracardiac pacemaker implantedat a target implant site.

FIG. 11 is a perspective view of a dual chamber intracardiac pacemakerhaving an alternative fixation member.

FIGS. 12A-12C are conceptual diagrams of components for assembling thedistal fixation member and electrode assembly of the intracardiacpacemaker according to one example.

FIG. 13 is a top view of a manifold included in a distal fixation memberand electrode assembly according to one example.

FIG. 14 is a block diagram of circuitry that may be enclosed within theintracardiac pacemaker housing to provide the functions of dual chamberpacing and sensing according to one example.

FIG. 15 is a flow chart of a method for using the dual chamberintracardiac pacemaker of FIG. 1.

FIG. 16 is a conceptual diagram of an intracardiac pacemaker having morethan one distal dart electrode.

FIG. 17 is a conceptual diagram of an intracardiac pacemaker having morethan one distal dart electrode according to another example.

FIG. 18 is a three dimensional perspective view of an intracardiacpacemaker configured for dual chamber cardiac pacing according to yetanother example.

FIG. 19 is a top schematic view of a unitary member including acontinuous ring carrying multiple non-tissue piercing electrodes whichmay be included in the pacemaker of FIG. 18.

FIG. 20 is a three dimensional, exploded view of the distal fixation andelectrode assembly of the pacemaker of FIG. 18.

FIG. 21 is a conceptual diagram of an atrial sensing channel and anatrial pacing circuit coupled to the multiple non-tissue piercingcathode electrodes via switching circuitry.

FIG. 22 is a three-dimensional view of a pacemaker according to anotherexample.

DETAILED DESCRIPTION

FIG. 1 is a conceptual diagram of a dual chamber intracardiac pacemaker10 implanted in a patient's heart 8. Pacemaker 10 is shown implanted inthe right atrium (RA) of the patient's heart 8 in a target implantregion 4. Pacemaker 10 includes a fixation member 20 that anchors adistal end of the pacemaker against the atrial endocardium in the targetimplant region 4. The target implant region 4 may lie between the Bundleof His 5 and the coronary sinus 6 and may be adjacent the tricuspidvalve 3. Pacemaker 10 may be a leadless pacemaker including a dartelectrode 12 having a straight shaft extending from the distal end ofthe pacemaker 10, through the atrial myocardium and the central fibrousbody, and into the ventricular myocardium 14 or along the ventricularseptum, without perforating entirely through the ventricular endocardialor epicardial surfaces. The dart electrode 12 carries an electrode atthe distal end of the shaft for positioning the electrode within theventricular myocardium for sensing ventricular signals and deliveringventricular pacing pulses. In some examples, the electrode at the distalend of the shaft is a cathode electrode provided for use in a bipolarpacing and sensing electrode pair. While a particular implant region 4is shown in FIG. 1 to enable an electrode of dart electrode 12 to bepositioned in the ventricular myocardium, it is recognized that apacemaker having the aspects disclosed herein may be implanted at otherlocations for dual chamber pacing, single chamber pacing with dualchamber sensing, single chamber pacing and/or sensing, or other clinicalapplications as appropriate.

FIG. 2 is an enlarged conceptual diagram of dual chamber intracardiacpacemaker 10 and anatomical structures of the patient's heart 8.Intracardiac pacemaker 10 includes a housing 30 that defines ahermetically sealed internal cavity in which internal components ofpacemaker 10 reside, such as a sensing circuit, therapy deliverycircuit, control circuit, memory, telemetry circuit, other optionalsensors, and a power source as generally described in conjunction withFIG. 14 below. The housing 30 may be formed from an electricallyconductive material including titanium or titanium alloy, stainlesssteel, MP35N (a non-magnetic nickel-cobalt-chromium-molybdenum alloy),platinum alloy or other bio-compatible metal or metal alloy. In otherexamples, housing 30 is formed from a non-conductive material includingceramic, glass, sapphire, silicone, polyurethane, epoxy, acetylco-polymer plastics, polyether ether ketone (PEEK), a liquid crystalpolymer, or other biocompatible polymer.

Housing 30 extends between a distal end 32 and proximal end 34 and isgenerally cylindrical in the examples presented herein to facilitatecatheter delivery, but housing 30 may be prismatic or other shapes inother examples. Housing 30 may include a delivery tool interface member26, e.g., at the proximal end 34, for engaging with a delivery toolduring implantation of pacemaker 10. One example of a delivery tool thatmay be used for delivering pacemaker 10 to an implant site is describedbelow in conjunction with FIG. 9.

All or a portion of housing 30 may function as an electrode duringpacing and/or sensing. In the example shown, a housing-based electrode24 is shown to circumscribe a proximal portion of housing 30. Whenhousing 30 is formed from an electrically conductive material, such as atitanium alloy or other examples listed above, portions of housing 30may be electrically insulated by a non-conductive material, such as acoating of parylene, polyurethane, silicone, epoxy or otherbiocompatible polymer, leaving one or more discrete areas of conductivematerial exposed to define proximal housing-based electrode 24. Whenhousing 30 is formed from a non-conductive material, such as a ceramic,glass or polymer material, an electrically-conductive coating or layer,such as a titanium, platinum, stainless steel, or alloys thereof, may beapplied to one or more discrete areas of housing 30 to form proximalhousing-based electrode 24. In other examples, proximal housing-basedelectrode 24 may be a component, such as a ring electrode, that ismounted or assembled onto housing 30. Proximal housing-based electrode24 may be electrically coupled to internal circuitry of pacemaker 10,e.g., via electrically-conductive housing 30 or an electrical conductorwhen housing 30 is a non- conductive material. In the example shown,proximal housing-based electrode 24 is located nearer to housingproximal end 34 than housing distal end 32 and is therefore referred toas a “proximal housing-based electrode” 24. In other examples, however,a housing-based electrode 24 may be located at other positions alonghousing 30, e.g., relatively more distally than the position shown.

At distal end 32, pacemaker 10 includes a distal fixation and electrodeassembly 36 including fixation member 20 and a dart electrode 12including shaft 40 extending distally away from housing distal end 32and carrying tip electrode 42 carried at or near the free, distal end ofshaft 40. Tip electrode 42 may have a conical or hemi-spherical distaltip with a relatively narrow tip diameter, e.g., less than 1 mm, forpenetrating into and through tissue layers without requiring a sharpenedtip or needle-like tip having sharpened or beveled edges that mightotherwise produce a cutting action that could lead to lateraldisplacement of the tip electrode 42 and undesired tissue trauma.

Shaft 40 of dart electrode 12 is a normally straight member and may berigid in some examples. In other examples, shaft 40 is relatively stiffpossessing limited flexibility in lateral directions. Shaft 40 may benon-rigid to allow some lateral flexing with heart motion. However, in arelaxed state, when not subjected to any external forces, shaft 40maintains a straight position as shown to hold tip electrode 42 spacedapart from housing distal end 32 at least at the height 47 of shaft 40.Dart electrode 12 is configured to pierce through one or more tissuelayers to position tip electrode 42 within a desired tissue layer, e.g.,the ventricular myocardium As such, shaft 40 has a height 47corresponding to the expected pacing site depth and may have arelatively high compressive strength along its longitudinal axis toresist bending in a lateral or radial direction when a longitudinalaxial force is applied against tip electrode 42 when pressed against theimplant site, e.g., by applying longitudinal pushing force to theproximal end 34 of housing 30 to advance dart electrode 12 into thetissue within the target implant region 4. Shaft 40 may belongitudinally non-compressive. Shaft 40 may be elastically deformablein lateral or radial directions when subjected to lateral or radialforces to allow temporary flexing, e.g., with tissue motion, but returnsto its normally straight position when lateral forces diminish. Whenshaft 40 is not exposed to any external force, or to only a force alongits longitudinal central axis, shaft 40 retains a straight, linearposition as shown.

Fixation member 20 may include one or more tines having a normallycurved position. The tines of fixation member 20 may be held in adistally extended position within a delivery tool as shown in FIG. 9.The distal tips of the fixation member tines penetrate the heart tissueto a limited depth before elastically curving back proximally into thenormally curved position (shown) upon release from the delivery tool.Aspects of fixation member 20 may correspond to the fixation membergenerally disclosed in U.S. 2016/0059002 A1 (Grubac, et al.) or in U.S.Pat. No. 9,119,959 (Rys et al.), both of which are incorporated hereinby reference in their entirety.

In some examples, distal fixation and electrode assembly 36 includes adistal housing-based electrode 22. In the case of using pacemaker 10 fordual chamber pacing and sensing, tip electrode 42 may be used as acathode electrode paired with proximal housing-based electrode 24serving as a return anode electrode. Alternatively, distal housing-basedelectrode 22 may serve as a return anode electrode paired with tipelectrode 42 for sensing ventricular signals and delivering ventricularpacing pulses. In other examples, distal housing-based electrode 22 maybe a cathode electrode for sensing atrial signals and delivering pacingpulses to the atrial myocardium in the target implant region 4. Whendistal housing-based electrode 22 serves as an atrial cathode electrode,the proximal housing-based electrode 24 may serve as the return anodepaired with tip electrode 42 for ventricular pacing and sensing and asthe return anode paired with distal housing-based electrode 22 foratrial pacing and sensing.

As shown in FIG. 2, the target implant region 4 in some pacingapplications is along the atrial endocardium 18, generally inferior tothe AV node 15 and the His bundle 5. The dart electrode 42 is providedwith a height 47 of shaft 40 that penetrates through atrial endocardium18 in the target implant region 4, through the central fibrous body 16and into ventricular myocardium 14 without perforating through theventricular endocardial surface 17. When the full height 47 of dartelectrode 12 is fully advanced into the target implant region 4, tipelectrode 42 rests within ventricular myocardium 14 and distalhousing-based electrode 22 is positioned in intimate contact with orclose proximity to atrial endocardium 18. Dart electrode 12 may have atotal combined height 47 of tip electrode 42 and shaft 40 ofapproximately 3 mm to 8 mm in various examples. The diameter of shaft 40may be less than 2 mm and may be 1 mm or less, or even 0.6 mm or less.

In some examples, dart electrode 12 is not provided as a fixation memberor having any fixation feature such as a hook, helix, barb or otherfeature that tends to resist retraction of dart electrode 12 from thetissue at the implant site. Without fixation member 20, dart electrode12 having a normally straight, linear shaft may easily slide in and outof the heart tissue, at least during the acute phase after implantation.For example, dart electrode 12 may have a normally straight position orshape when not subjected to external forces and be isodiametric from itsfixed attachment point at housing distal end 32 to the base of tipelectrode 42. Tip electrode 42 may have a maximum diameter at its basethat interfaces with shaft 40 with the maximum diameter beingisodiametric with shaft 40 (see, for example, FIG. 6). The diameter oftip electrode 40 may decrease from the base toward the distal tip of tipelectrode 42, e.g., according to a conical or hemispherical shape of thetip electrode 42. In other examples, tip electrode 42 may be cylindricalwith a relatively flat, blunted or rounded tip. The distal tip of tipelectrode 42 may be blunted or rounded to avoid a sharp cutting point oredge.

FIG. 3 is a three-dimensional perspective view of intracardiac pacemaker10 capable of dual chamber pacing and sensing according to one example.Pacemaker 10 has a distal fixation and electrode assembly 36 thatincludes a distal housing-based electrode 22 implemented as a ringelectrode. The distal housing-based electrode 22 is positioned inintimate contact with or operative proximity to atrial tissue whenfixation member tines 20 a, 20 b and 20 c of fixation member 20, engagewith the atrial tissue. As described below in conjunction with FIG. 9,tines 20 a, 20 b and 20 c, which are elastically deformable, may beextended distally during delivery of pacemaker 10 to the implant site.For example, tines 20 a, 20 b, and 20 c pierce the atrial endocardialsurface as the pacemaker 10 is advanced out of the delivery tool andflex back into their normally curved position (as shown) when no longerconstrained within the delivery tool. As the tines 20 a, 20 b and 20 ccurve back into their normal position, the fixation member 20 acts topull distal fixation member and electrode assembly 36 toward the atrialendocardial surface. As the distal fixation member and electrodeassembly 36 is pulled toward the atrial endocardium, tip electrode 42 isadvanced through the atrial myocardium and the central fibrous body andinto the ventricular myocardium Distal housing-based electrode 22 maythen be positioned against the atrial endocardial surface.

Distal housing-based electrode 22 may be a ring formed of anelectrically conductive material, such as titanium, platinum, iridium oralloys thereof. Distal housing- based electrode 22 may be a singlecontinuous ring electrode. In other examples, portions of the ring maybe coated with an electrically insulating coating, e.g., parylene,polyurethane, silicone, epoxy, or other insulating coating, to reducethe electrically conductive surface area of the ring electrode. Forinstance, one or more sectors of the ring may be coated to separate twoor more electrically conductive exposed surface areas of distalhousing-based electrode 22. Reducing the electrically conductive surfacearea of distal housing-based electrode 22, e.g., by covering portions ofthe electrically conductive ring with an insulating coating, mayincrease the electrical impedance of distal housing- based 22 andthereby reduce the current delivered during a pacing pulse that capturesthe myocardium, e.g. the atrial myocardial tissue. A lower current drainconserves the power source, e.g., one or more rechargeable ornon-rechargeable batteries, of pacemaker 10.

As described above, distal housing-based electrode 22 may be configuredas an atrial cathode electrode for delivering pacing pulses to theatrial tissue at the implant site in combination with the proximalhousing-based electrode 24 as the return anode. Electrodes 22 and 24 maybe used to sense atrial P-waves for use in controlling atrial pacingpulses (delivered in the absence of a sensed P-wave) and for controllingatrial-synchronized ventricular pacing pulses delivered using tipelectrode 42 as a cathode and proximal housing-based electrode 24 as thereturn anode. In other examples, the distal housing-based electrode 22may be used as a return anode in conjunction with the cathode tipelectrode 42 for ventricular pacing and sensing.

FIG. 4 is a side perspective view of intracardiac pacemaker 10 accordingto another example in which pacemaker 10 may be configured for dualchamber pacing and sensing. In this example, the distal fixation memberand electrode assembly 36 carries a distal housing-based electrode 52that extends circumferentially around the periphery of assembly 36,along circumferential surface 39. In other examples, the distalhousing-based electrode 52 may extend circumferentially around housing30, proximal to the assembly 36 but distal to the proximal housing-basedelectrode 24 and electrically isolated from proximal housing-basedelectrode 24. For example, housing 30 may be formed from an electricallynon-conductive material, e.g., glass or ceramic, such that two or morehousing- based electrodes 22 and 24 may extend circumferentially aroundhousing 30, electrically isolated from one another and individuallycoupled via respective electrical feedthroughs to electronic circuits,such as sensing and/or pacing circuits, enclosed within housing 30.

In another example, distal fixation member and electrode assembly 36 mayinclude multiple distal housing-based electrodes, e.g., one or moreelectrodes along its distal surface 38 and/or one or more electrodesalong its circumferential surface 39. For example, assembly 36 mayinclude a ring electrode along the distal surface 38 as shown in FIG. 3or one or more button electrodes along the distal surface 38 asdescribed below in conjunction with FIG. 5, and a ring electrodecircumscribing the circumferential surface 39 as shown in FIG. 4. Thedistal housing-based electrodes may be individually selectable forelectrical coupling to sensing and/or pacing circuits enclosed byhousing 30 for use individually or in any combination as an electrodehaving a single polarity or as a combination of electrodes having dualpolarity. For example, a single distal housing-based electrode or acombination of single-polarity distal housing-based electrodes may serveas an anode paired with tip electrode 42 serving as the cathode forventricular pacing. A single distal housing-based electrode or acombination of single-polarity distal housing- based electrodes mayserve as an atrial cathode electrode paired with the proximalhousing-based electrode 24 serving as the anode. In other examples, acombination of distal housing-based electrodes may be selected as ananode and cathode pair for atrial pacing and sensing.

FIG. 5 is a three-dimensional perspective view of dual chamberintracardiac pacemaker 10 according to another example. In this example,dart electrode 12 includes a conical tip electrode 42 having a base 43that has a greater diameter than the outer diameter 45 of shaft 40. Thedistal tip 44 of tip electrode 42 may be blunted to avoid a sharp tipand high current density at the pacing site.

The distal housing-based electrode 62 includes one or more buttonelectrodes, three button electrodes 62 a, 62 b and 62 c in this examplereferred to collectively as distal housing-based electrode 62, allpositioned along the distal surface 38 of the distal fixation member andelectrode assembly 36. The three button electrodes 62 a, 62 b, and 62 cmay be electrically coupled together to function as a single electrode.The separate button electrodes 62 a, 62 b, and 62 c may have a totalsurface area that is smaller than a continuous ring electrode, such asthe distal housing-based electrode 22 shown in FIG. 3 or the distalhousing-based electrode 52 in FIG. 4. The smaller total surface area ofdistal housing-based electrode 62 increases the electrical impedance ofthe pacing load, reducing pacing current and battery drain of pacemaker10. In one example, the surface area of each button electrode 62 a, 62 band 62 c is 1.2 square mm or less for a combined total surface area of3.6 square mm or less.

In other examples, the three button electrodes 62 a, 62 b, and 62 c areindividually selectable by switching circuitry included in theelectronics enclosed by housing 30. Each electrode 62 a, 62 b, and 62 cmay be electrically coupled individually to a pacing circuit and/or asensing circuit enclosed in housing 30 so that the electrodes 62 a, 62b, and 62 c can be selected one at a time, two at a time, or all threeat a time, e.g., to serve as an atrial cathode electrode for sensingatrial signals and delivering atrial pacing pulses.

The separate button electrodes 62 a, 62 b and 62 c may be distributed atequal distances along distal surface 38, peripherally to dart electrode12, which is centered co-axially with the longitudinal axis 31 ofhousing 30. For instance, the arc separating each adjacent pair ofelectrodes 62 a, 62 b, and 62 c may be 120 degrees. When distal surface38 is pulled against the atrial endocardium by fixation member 20, oneor two of electrodes 62 a, 62 b and 62 c may have better contact withthe atrial endocardium than the other one or two of electrodes 62 a, 62b and 62 c depending on the anatomy at the implant site and the angle ofentry of dart electrode 12 and fixation member 20 at the implant site.By spacing apart electrodes 62 a, 62 b, and 62 c along the distalsurface 38, e.g., at different radial locations, at least one electrode62 a, 62 b and 62 c is expected to have good contact with theendocardium for achieving reliable atrial sensing and pacing.

Electrodes 62 a, 62 b and 62 c are shown spaced between a like-number oftines of fixation member 20 in FIG. 5. Each electrode 62 a, 62 b and 62c is approximately centered between two adjacent tines of fixationmember 20. In other examples, each electrode 62 a, 62 b and 62 c may beradially aligned with a tine of fixation member 20 to promote intimatecontact between the endocardial surface and the electrodes 62 a, 62 band 62 c. While three button electrodes 62 a, 62 b and 62 c are shown inFIG. 5, it is recognized that the distal housing-based electrode 62 maycomprise less than three, as few as one, or more than three buttonelectrodes distributed along the distal surface 38 of fixation memberand electrode assembly 36 at equal or non-equal intervals or arcs.Furthermore, distal fixation member and electrode assembly 36 is notrequired to have an equal number of electrodes defining distalhousing-based electrode 62 and tines included in fixation member 20;fewer or more electrodes may be provided along distal surface 38 thanthe number of fixation member tines.

The electrodes 62 a, 62 b and 62 c may be raised as shown in FIG. 5 suchthat the surfaces of the electrodes 62 a, 62 b and 62 c protrude fromthe distal surface 38 for making better contact with the atrialendocardium at the implant site. In other examples, the electrodes 62 a,62 b and 62 c may be flush with distal surface 38. Distal surface 38 isshown as a convex surface. In other examples distal surface 38 may bemore or less convex than shown here and may be adapted to match theanatomy at the implant site to promote contact of the distalhousing-based electrode 62 with the atrial endocardium In still otherexamples, one or more button electrodes 62 a, 62 b and 62 c may bepositioned along the circumferential surface 39 of assembly 36.

FIG. 6 is a sectional view of a distal portion of intracardiac pacemaker10, capable of dual chamber pacing and sensing. In some examples, distalfixation member and electrode assembly 36 includes an inner body 70 andouter ring 72 for supporting and retaining fixation member 20, dartelectrode 12, and distal housing-based electrode 62 and coupling thesecomponents to housing 30 (and its internal components as needed). Amethod of assembling these various components is described below inconjunction with FIGS. 12A-12C. Fixation member 20 may include one ormore curving tines that extend from a fixation member ring 224 that isretained between interlocking faces of inner body 70 and outer ring 72.Inner body 70 and outer ring 72 may be molded components includingpolyurethane, silicone, epoxy, PEEK, polyethylene, or otherbiocompatible polymer materials and may include various conduits,lumens, cavities, grooves or other features for receiving and retainingshaft 40, housing-based electrode 62, electrical conductors and otherassembly components as needed. Other aspects of distal fixation memberand electrode assembly 36 are described below in conjunction with FIGS.12A 12C.

In this example, shaft 40 includes an electrical conductor 46electrically coupled to and extending from tip electrode 42 to anelectrical feedthrough wire 250 that provides electrical connectionacross housing 30 via electrical feedthrough 50. The electricalconductor 46 is shown as a coiled conductor in this example but may be abraided, twisted or other multi-filar conductor or single strand wire inother examples. Shaft 40 further includes a tubular body 48 thatelectrically insulates electrical conductor 46 and, in conjunction withelectrical conductor 46, provides shaft 40 with the mechanicalproperties of a high compressive strength along its longitudinal centralaxis 31 and, in some examples, lateral elastic deformability. Dartelectrode 12 possesses high compressive strength so that it canpenetrate into and through tissue layers with little or no compressionor flexing due to longitudinal forces against tip electrode 42. Dartelectrode 12 may possess some flexibility in lateral directions whensubjected to lateral forces due to heart motion. Tubular body 48 may bea coating or overmolded component that is applied over electricalconductor 46 to enclose and circumscribe conductor 46. In some examples,tubular body 48 may become bonded to electrical conductor 46 during theovermolding process. In other examples, tubular body 48 may be apre-formed, extruded or molded tubular component that receiveselectrical conductor 46 during the assembly process. Tubular body 48 maybe an electrically insulating material and may include parylene,polyurethane, epoxy, PEEK, silicone or other biocompatible polymers. Inother examples, tubular body 48 may be an electrically conductivematerial, e.g., stainless steel, titanium or titanium alloy, with itsouter exposed surface coated with an electrically insulating material.

Tip electrode 42 includes a shank portion 42 a and an active, exposedelectrode portion 42 b that is exposed at the distal end of shaft 40.Shank portion 42 a may be unexposed to the surroundingtissue/environment and is electrically coupled to electrical conductor46 and mechanically coupled to shaft 40. For example, shank portion 42 amay extend through at least a portion of an inner lumen 60 defined bytubular body 48 and coiled electrical conductor 46 and may extendfurther than shown, e.g., half or even all of the way to inner body 70.In other examples, shank portion 42 a is a tubular member that extendsinto tubular body 48 and receives a portion of electrical conductor 46within an inner lumen defined by shank portion 42 a for both mechanicaland electrical coupling between conductor 46 and tip electrode 42. Shankportion 42 a may contribute to the mechanical properties of dartelectrode 12 of being longitudinally non-compressible and, at least insome examples, being laterally elastically deformable.

If needed, a central member 61 may extend within lumen 60 to achieve thedesired mechanical properties of dart electrode 12 being longitudinallynon-compressible and laterally elastically deformable. Central member 61may be a solid support member, a spring, a cable, a tube or rod and mayinclude a metal or plastic material that provides high longitudinalcompression strength and/or lateral elastic deformability. In otherexamples, central member 61 may be a steroid-impregnated polymer memberthat provides steroid elution over time through the exposed tipelectrode portion 42 b. For example, central member 61 may be amonolithic controlled release device (MCRD) including a polymer matrix,e.g., a silicone or polyurethane base, and a steroid, e.g., sodiumdexamethasone phosphate, compounded in the polymer matrix.

The active electrode portion 42 b of tip electrode 42 is exposed at thedistal end of shaft 40 and is shown as substantially conical with arounded or blunted tip 44, as opposed to having a sharpened tip that maybe damaging to surrounding tissue or create a point of high currentdensity during pacing. The exposed electrode portion 42 b has a base 43that is isodiametric with the outer diameter 45 of tubular body 48. Inthis way, dart electrode 12 slides into the heart tissue at the desiredimplant site with minimized resistance and may be easily be retractedfrom the implant site if pacemaker 10 ever needs to be removed.

Exposed electrode portion 42 b may be sintered, e.g., sintered platinumiridium Tip electrode 42 may be a steroid-eluting electrode having asintered active electrode portion 42 b and a hollow, tubular shankportion 42 a that allows steroid eluting from a steroid eluting member,e.g., central member 61 in some examples, to be released through tipelectrode 42 into surrounding tissue to reduce the foreign body responseat the pacing and sensing site.

Shaft 40 may include a base 49 that circumscribes tubular body 48 and isretained within inner body 70. Base 49 provides mechanical support to awelded, electrical connection between electrical conductor 46 andfeedthrough wire 250. In some examples, feedthrough wire 250 is weldedto a shaft receiving pin 254 of a shaft mounting member 252. Shaftmounting member 252 may be an electrically conductive member that iselectrically coupled to conductor 46 by mounting shaft 40 over shaftreceiving pin 254 of shaft mounting member 252. The physical contact ofthe electrically conductive shaft receiving pin 254 and electricalconductor 46 may provide electrical connection between electricalconductor 46 and feedthrough wire 250, which is welded or otherwiseelectrically coupled to shaft mounting member 252. Base 49 of shaft 40provides electrical insulation and mechanical support to theseconnections. Base 49 may be a polymer tubular member that is sealed andbonded to the outer tubular body 48 of shaft 40, e.g., using medicaladhesive. Base 49 may rest against an interior stopping surface 78 ofinner body 70 to prevent dart electrode 12 from being pulled away frominner body 70.

Shaft mounting member 252 is mounted on a manifold 240 that directsfeedthrough wire 250 toward dart electrode 12 and other feedthroughwires (not shown in FIG. 6) to distal housing-based electrode 62.Manifold 240 includes a central lumen 244 that passes feedthrough wire250 from electrical feedthrough 50 to shaft mounting member 252.Manifold 240 may be adhesively bonded to the distal end cap 228 ofhousing 30 and over feedthrough 50.

Distal end cap 228 may include one or more interior, radially-outwardextending tabs 230. Inner body 70 may include one or moreradially-inward extending tabs 73 that engage and mate with respectiveoutward extending tabs 230. During assembly, inner body 70 may beadhesively bonded to outer ring 72 with fixation member ring 224 trappedbetween inner body 70 and outer ring 72 to form a subassembly. Thesubassembly may be assembled with the dart electrode 12 and thenattached to housing distal end cap 228 by seating inner body 70 ontodistal end cap 228 with inward extending tabs 73 positioned betweenoutward extending tabs 230, within spaces defined by spaced apartoutward extending tabs 230 (as best seen in FIG. 12A). Once seatedagainst distal end cap 228, the entire fixation member and electrodeassembly 36 may be rotated relative to housing 30 (and housing distalend cap 228) such that radially inward extending tabs 73 of inner body70 become entrapped underneath radially outward extending tabs 230 ofdistal end cap 228. Medical adhesive may be used to fill and seal anygaps or spaces and bond the various interfacing surfaces of the distalfixation member and electrode assembly 36 and housing 30. In this way,distal fixation member and electrode assembly 36 may be fixedly coupledto housing 30.

FIG. 7 is a side perspective view of pacemaker 10 according to anotherexample. In this example, dart electrode 12 includes a rounded,cylindrical tip electrode 42 instead of a conical tip electrode as shownin FIG. 6. The distal tip 44 of tip electrode 42 is made a blunt aspossible, with rounded edges, to avoid any tissue cutting action andpoints of high current density. As diameter of base 43 increases (or thediameter 45 of shaft 40 increases), the diameter at tip 44 may need todecrease or become more pointed, e.g., as shown by the conical shape oftip electrode 42 in FIG. 6, in order to penetrate the heart tissue witha force that is reasonably achievable during surgical implantation. Forexample, the larger and more blunt tip 44 becomes, the greater the forcerequired to advance dart electrode 12 into and through the atrialmyocardium and central fibrous body to position tip electrode 42 in theventricular myocardium The smaller the diameter 45 of shaft 40 andisodiametric base 43 of tip electrode 42 are, the more rounded or bluntdistal tip 44 can be while still enabling penetration and advancementthrough the heart tissue. The longitudinal force applied to dartelectrode 12 may be applied at the housing proximal end 34 by a usermanipulating a delivery tool and/or by the pulling force of fixationmember 20 as it elastically flexes from an extended position back to itsnormally curved position.

FIG. 8 is a side perspective view of dual chamber intracardiac pacemaker10 according to another example. In the examples described above, shaft40 of dart electrode 12 has an outer tubular body 48 (see FIG. 6) thatis electrically non-conductive and insulates the electrical conductor 46that electrically couples tip electrode 42 to the circuitry enclosed byhousing 30. The active tip electrode portion 42 b is the onlyelectrically conductive surface of dart electrode 12 that is exposed tothe surrounding tissue/environment. In the example shown in FIG. 8, dartelectrode 12 includes a second electrode 64 carried by shaft 40. Secondelectrode 64 may be a ring electrode that is mounted around shaft 40 ormounted between shaft 40 and the distal surface 38 of fixation memberand electrode assembly 36. In one example, tip electrode 42 and second(ring) electrode 64 of dart electrode 12 are coupled to respectivecoiled, braided, twisted, stranded or wire conductors and the conductorsare overmolded with an electrically insulating coating to form tubularbody 48, leaving the active surface areas of electrodes 42 and 64exposed.

In other examples, the tubular body of shaft 40 may be an electricallyconductive metal body having an insulating coating, e.g., parylene orother examples given herein, covering its outer surface except for theexposed area of electrode 64 and insulating shaft 40 from tip electrode42. The insulating coating insulates electrodes 42 and 64 from eachother so that they may serve as mutually exclusive electrodes.

The second electrode 64 carried by shaft 40 may serve as an anodeelectrode paired with tip electrode 42 serving as a cathode fordelivering ventricular pacing pulses and sensing ventricular signals.For instance, the second electrode 64 carried by shaft 40 may beelectrically coupled to housing 30 or electrical ground via an insulatedconductor extending from shaft 40, through fixation member and electrodeassembly 36. In other examples, the second electrode 64 may be a cathodeelectrode and tip electrode 42 may be an anode electrode.

In other examples, the second electrode 64 may function as an atrialcathode electrode and be electrically coupled to an atrial sensingchannel and an atrial pacing channel of respective sensing and pacingcircuits enclosed by housing 30. In this case, the tip electrode 42 mayserve as a ventricular electrode, e.g., a cathode electrode, and thering electrode 64 provided as a second electrode along shaft 40 proximalto tip electrode 42 may serve as an atrial electrode, e.g., an atrialcathode electrode. In this example, each cathode electrode, tipelectrode 42 and ring electrode 64, may be paired with the same ordifferent anode electrodes, which may be carried along distal surface 38of fixation member and electrode assembly 36, such as distalhousing-based electrode 62 provided as a button electrode, a ringelectrode circumscribing fixation member and electrode assembly 36 (suchas electrode 52 shown in FIG. 4), or the proximal housing-basedelectrode 24.

FIG. 9 is a conceptual diagram of dual chamber intracardiac pacemaker 10loaded in a delivery tool 100. Delivery tool 100 includes an outercatheter 102, advancement tool 104, tether 106 and may include an innersteering tool 107. Outer catheter 102 has a distal device receptacle 108for receiving and retaining pacemaker 10. Receptacle 108 has a distalopening 110 through which pacemaker 10 may be loaded into delivery tool100 and released from delivery tool 100 at an implant site. Advancementtool 104 extends through an inner lumen of outer catheter 102 and mayinclude a distal pusher cone or cup 105 configured to interface with theproximal end 34 of housing 30 for advancing housing 30 out distalopening 110 when advancement tool 104 is advanced distally through outercatheter 102. A tether 106, which may be provided as an elongated bodyor suture, may extend through advancement tool 104 and be removablyattached or looped through the delivery tool interface 26 of pacemaker10. Tether 106 may be used by a clinician to retract on pacemaker 10 toretain pacemaker 10 within receptacle 108 during advancement of thedelivery tool 100 to an implant site.

Inner steering tool 107 may be an elongated tubular body that extendsthrough a lumen defined by advancement tool 104. Inner steering tool 107may be a steerable body that can be used to steer distal opening 110 tothe target implant region 4 (shown in FIG. 1). In some examples, innersteering tool 107 may define an inner lumen through which a steeringmember such as a guide wire extends. In this case, inner steering tool107 may be a passive tubular body that follows the contour of the innersteering member or guidewire.

Pusher cup 105 is sized to mate and removably engage with the housingproximal end 34 and delivery tool interface member 26. Tether 106 may beused to retract and retain pacemaker 10 in receptacle 108 as long asadvancement tool 104 remains in a retracted position (as shown) withinouter catheter 102. When distal opening 110 has been steered to adesired implant site, tension on tether 106 may be lessened asadvancement tool 104 is advanced distally in outer catheter 102 suchthat pusher cup 105 advances distally through receptacle 108, pushingpacemaker 10 out of distal opening 110.

Fixation member 20 is shown held in an extended position within theconfines of receptacle 108. When distal opening 110 is placed near oragainst the endocardial tissue at a target implant region, e.g., region4 of FIG. 1, and pacemaker 10 is pushed out of distal opening 110 byadvancement tool 104, the distal tip 21 of each tine of fixation member20 pierces the atrial endocardial surface and advances partially intothe myocardial tissue until the fixation member 20 is advanced farenough out of receptacle 108 that the pre- formed curved tines offixation member 20 are no longer confined and begin to elastically curveor bend back into their normally relaxed, curved position. Afterdeployment of fixation member 20, tether 106 may be retracted to bereleased from delivery tool interface member 26, and delivery tool 100may be retracted and removed leaving pacemaker 10 actively fixed at theimplant site. Aspects of the delivery tool 100 and fixation member 20may correspond to the medical device fixation apparatus and techniquesgenerally disclosed in pending U.S. Patent Publication No. 2012/0172892(Grubac, et al.), incorporated herein by reference in its entirety.

FIG. 10 is a conceptual diagram of pacemaker 10 implanted at a targetimplant site. As shown in the implanted position of FIG. 10, the distaltip 21 of each tine of fixation member 20 may exit back out of theatrial endocardial surface 18 such that tissue becomes engaged withinthe curved portion of each tine of fixation member 20. As fixationmember 20 becomes engaged with the atrial myocardium 19, dart electrode12 pierces into the tissue at the target tissue region and advancesthrough the atrial myocardium 19 and central fibrous body 16 to positiontip electrode 42 in the ventricular myocardium 14 as shown in FIG. 10.The distal housing-based electrode 22, shown as a ring electrode in FIG.10, may be held in contact with the atrial endocardial surface 18 byfixation member 20. Retraction of dart electrode 12 out of theventricular myocardium 14 is prevented by fixation member 20. Asdescribed above, dart electrode 12 may be linear and isodiametric fromthe conical, cylindrical or hemispherical tip electrode 42 to itsattachment point on the distal surface of the fixation member andelectrode assembly 36 such that there are no protrusions, hooks, barbs,helices or other features that would resist retraction of dart electrode12. Fixation member 20 is the sole fixation feature of pacemaker 10 insome examples.

The height 47 of dart electrode 12 is selected to ensure tip electrode42 reaches an adequate depth in the tissue layers to reach the targetedpacing and sensing site, in this case in the ventricular myocardium,without puncturing all the way through into an adjacent cardiac chamber.Height 47 may be at least 3 mm but is less than 20 mm, less than 15 mm,less than 10 mm or up to 8 mm in various examples.

Referring again to FIG. 9, tip electrode 42 and distal tip 21 of eachtine affixation member 20 in the extended position may extendapproximately equidistant from housing distal end 32. The tines offixation member 20 in the extended position shown in FIG. 9 and dartelectrode 12 may extend to the same height 47 from the connection pointof shaft 40 to assembly 36. In this case, tip electrode 42 and tinedistal tips 21 of fixation member 20 will pierce the tissue at theimplant site simultaneously as pacemaker 10 is advanced out distalopening 110. Manual pressure applied to the housing proximal end 34 viaadvancement tool 104 provides the longitudinal force required to piercethe cardiac tissue at the implant site.

In other examples, the tine distal tip 21 may extend a height from theproximal base of shaft 42 that is greater than the height 47 of dartelectrode 12 when fixation member 20 is held in the extended positionwithin receptacle 108. Distal tine tips 21 pierce the tissue first inthis case, before tip electrode 42, and may act to pull pacemaker 10toward the atrial endocardial surface 18 as fixation member elasticallybends or curves back into its normally curved position. This pullingforce produced by fixation member 20 may contribute to the longitudinalforce that drives tip electrode 42 into the tissue at the implant siteand advances tip electrode 42 to the ventricular pacing site. In someexamples, the pulling force produced by fixation member 20 may be theonly force required to drive dart electrode 12 into the heart tissue toa desired depth in the ventricular myocardium to achieve dual chamberpacing and sensing functionality.

In still other examples, the height 47 of dart electrode 12 may begreater than the distance that tine distal tips 21 extend when held inthe extended position shown in FIG. 9. In this case, the tip electrode42 pierces the atrial endocardium first and advances partially into thetissue layers before the tine distal tips 21 of fixation member 20 enterthe endocardial tissue. For instance, tip electrode 42 may advance atleast partially through the atrial myocardium and the fixation member 20may act to increase the longitudinal force driving tip electrode 42through the central fibrous body and into the ventricular myocardium bypulling pacemaker 10 toward the atrial endocardial surface as the tinesof fixation member 20 elastically return to their normally curvedposition.

FIG. 11 is a three-dimensional perspective view of an intracardiacpacemaker 10 having an alternative fixation member 120. The intracardiacpacemaker 10 may be dual chamber pacemaker having a distal dartelectrode 12 for pacing and sensing in the ventricular myocardium may beanchored in an atrial chamber using other fixation members than theelastically-deformable, tissue penetrating tines shown in example offixation member 20 given above. In the example of FIG. 11, fixationmember 120 includes two tissue engaging portions that extend from afixed end 122 attached to fixation member and electrode assembly 36 to atissue-piercing distal tip 124 along a peripheral, helical path.Fixation member 120 may generally correspond to the tissue engagingportions of the electrode assembly disclosed in U.S. Pat. No. 8,948,883(Eggen, et al.), incorporated herein by reference in its entirety.

Pacemaker 10 may be implanted at a tissue site by advancing dartelectrode 12 into the tissue, e.g., the atrial myocardium, by applyingforce along the center, longitudinal axis of housing 30 and dartelectrode 12 using an advancement tool, such as the advancement tool 104shown in FIG. 9. In other examples, an axial force along thelongitudinal center axis of housing 30 and dart electrode 12 may beapplied while also applying a rotational force using the delivery tool,e.g., by rotating advancement tool 104 or the entire delivery tool 100,to advance dart electrode 12 into the implant site by both rotation andaxial force. When the piercing distal tip 124 of fixation member 120reaches the tissue surface, e.g., the atrial endocardial surface,pacemaker 10 is rotated (clockwise for the orientation of the tissueengaging portions shown) to advance fixation member 120 into the tissuesite and further advance dart electrode 12 to the ventricular sensingand pacing site. The engagement and advancement of fixation member 120into the tissue at the implant site may contribute to the longitudinalforce that advances dart electrode 12 through the tissue layers and intothe ventricular myocardium Fixation member 120 prevents retraction ofdart electrode 12 from the ventricular pacing site.

Dart electrode 12 is shown having a height that extends a greaterdistance from distal surface 38 than the distal piercing tips 124 offixation member 120. In other examples, the tissue engaging portions offixation member 120 may have a greater length than shown in FIG. 11 suchthat distal piercing tips 124 and the tip 44 of tip electrode 42 areequidistant from distal surface 38 and enter the tissue simultaneously.Alternatively, distal piercing tips 124 may extend to a height fromdistal surface 38 beyond the height of dart electrode 12. In this case,rotation of pacemaker 10 advances fixation member 120 into the cardiactissue at the implant site first, and then dart electrode 12 is advancedinto and through the tissue layers until the tip electrode 42 reaches aventricular pacing site. Advancement of the fixation member 120 into thetissue by rotation of pacemaker 10 may produce the only longitudinalforce needed to advance dart electrode 12 through the tissue layers intothe ventricular myocardium In other cases, additional longitudinal forceapplied at housing proximal end 34 may be required to fully advance dartelectrode 12 to its final position.

FIGS. 12A-12C are conceptual diagrams of components and a method ofassembling distal fixation member and electrode assembly 36 and couplingthe assembly 36 to housing 30. FIG. 12A is an exploded view of distalfixation member and electrode assembly 36 according to one example.Assembly 36 may include an inner body 70 and outer ring 72, which may bemolded interlocking components shown assembled together in FIG. 12A.Fixation member 220 includes one or more tines 220 a, 220 b, 220 c, and220 d extending from a fixation member ring 224 that may be captured andretained between the inner body 70 and outer ring 72.

Insulated, electrically conductive feedthrough wires 232 and 250 extendfrom within housing 30 out through an electrical feedthrough 50extending through distal end cap 228 of housing 30. Feedthrough wires232 provide electrical connection between circuitry internal to housing30 to each one of the distal housing-based electrodes 262, whichcomprises four button electrodes 262 a, 262 b, 262 c, and 262 d in thisexample. Feedthrough wire 250 provides electrical connection from theinternal circuitry to tip electrode 42. Distal end cap 228 includesspaced apart, radially-outward extending tabs 230, for interlocking withradially-inward extending tabs 73 of inner body 70 (as best seen in FIG.6).

A manifold 240 may be provided having radially-extending, horizontalchannels 242 for guiding each one of the multiple feedthrough wires 232to a respective button electrode 262 a-d and a central lumen 244 forpassing feedthrough wire 250 for electrical coupling to the electricalconductor 46 (shown in FIG. 6) of dart electrode 12. A shaft mountingmember 252 may be provided for mechanically coupling and supporting theshaft 40 of dart electrode 12. In some examples, shaft mounting member252 may provide electrical coupling between feedthrough wire 250 and theelectrical conductor 46 (see FIG. 6) within shaft 40 and providesmechanical support of the electrical connection.

Dart electrode 12 may be provided as a subassembly having tip electrode42 mounted at the distal end of shaft 40 (as described above inconjunction with FIG. 6) and electrically coupled to an electricalconductor 46 extending through shaft 40 to facilitate electricalconnection of tip electrode 42 to feedthrough wire 250. Shaft 40 mayinclude a rigid tubular body or a semi-rigid tubular body that ispre-molded or overmolded to enclose the electrical conductor 46 withinas described above. Shaft 40 may be non-compressive longitudinally towithstand compressive forces along the longitudinal central axis of dartelectrode 12 during insertion of dart electrode 12 into cardiac tissueand advancement of tip electrode 42 to a ventricular pacing site. Shaft40 may possess lateral flexibility by being elastically deformable inlateral directions. Shaft 40 may be provided with a proximal base 49configured to seal and reinforce the connection between shaft 40 andshaft mounting member 252.

FIG. 12B is a conceptual diagram of the partially-assembled distalfixation member and electrode assembly 36. Manifold 240 is mounted ondistal end cap 228 of housing 30 with feedthrough wires 232 and 250threaded through manifold 240. Medical adhesive may be applied over theelectrical feedthrough 50 to fixedly couple and seal manifold 240 inplace over the feedthrough 50 and on distal end cap 228. Shaft mountingmember 252 is mounted on top of manifold 240. Shaft-receiving pin 254may be aligned with the central longitudinal axis of housing 30.Shaft-receiving pin 254 is configured to mate with the proximal end ofshaft 40 and may guide a feedthrough wire 250 through a central lumen ofpin 254 for electrical coupling to the electrical conductor 46 (shown inFIG. 6) extending within shaft 40. In some examples, feedthrough wire250 is electrically coupled to shaft-receiving pin 254, and shaftreceiving pin 254 is electrically coupled to electrical conductor 46.

In some examples, base 49 is a slidable member that may be advanceddistally over shaft 40 during assembly of dart electrode 12 ontoshaft-receiving pin 254. Base 49 may be slid down over the junctionbetween shaft receiving pin 254 and shaft 40 to seal, insulate andmechanically reinforce the connections between shaft receiving pin 254,feedthrough wire 250 and the electrical conductor 46 extending withinshaft 40. In various examples, welding, adhesive bonding or otherbonding methods appropriate for the particular material of shaftmounting member 252 and shaft base 49 may be used to fixedly couple thebase 49 of dart electrode 12 to the shaft mounting member 252.

The outer ring 72 and inner body 70 may be sealed together with medicaladhesive to form a subassembly including the fixation member 220retained between outer ring 72 and inner body 70. Inner body 70 ofassembly 36 defines a central lumen 76 for passing over dart electrode12 after it is assembled onto shaft mounting member 252. Inner body 70further defines electrode cavities 74 for receiving and retaining buttonelectrodes 262 a-d. Each of the feedthrough wires 232 corresponding toeach of button electrodes 262 a-d may be directed toward the respectiveelectrode cavities 74 by manifold 240 to facilitate electrical couplingto respective electrodes 262 a-d. After passing inner body 70 over dartelectrode 12, each of the remaining feedthrough wires 232 correspondingto distal housing-based electrodes 262 a-d are passed through anelectrode receiving cavity 74 to enable electrical coupling of eachfeedthrough wire 232 to a respective one of distal housing-based buttonelectrodes 262 a-262 d.

FIG. 12C is a conceptual diagram of the completed assembly of distalfixation member and electrode assembly 36. Inner body 70 and outer ring72 may be aligned with housing 30 to pass over radially-outwardextending tabs 230 then rotated to lock radially- inward extending tabs73 (shown in FIG. 6) in place beneath radially-outward extending tabs230, with inner body 70 seated over shaft mounting member 252. In otherexamples, inner body 70 and/or outer ring 72 may include a groove,thread, flange or other feature or combination of features that matewith corresponding features included on distal end cap 228 for aligningand fixedly coupling distal fixation member and assembly 36 with housing30.

Electrodes 262 may be press fit and sealed or welded into place withinrespective cavities 74. Trimming (as needed) and spot welding offeedthrough wires 232 to each respective electrode 262 is performed.Medical adhesive, such as silicone adhesive, or other bonding andsealing materials may be applied at joints between dart electrode 12,inner body 70, distal housing-based electrodes 262, outer ring 72 andhousing 30 as needed to fixedly couple components of distal fixationmember and electrode assembly 36 and housing 30 and promote hermeticsealing and electrical insulation of electrically conductive componentsfrom body tissue and fluids(other than intentionally exposed electrodesurfaces).

FIG. 13 is a top view of manifold 240. Manifold 240 includes a centrallumen 244 extending from the bottom surface to the top surface ofmanifold 240 to pass the feedthrough wire 250 that is electricallycoupled to dart electrode 12. In the case of a second electrode carriedby the shaft 40 of dart electrode 12, e.g., as shown in FIG. 8, morethan one central lumen may be provided or central lumen 244 mayaccommodate more than one insulated feedthrough wire.

Manifold 240 includes one or more peripheral lumens 243 extending fromthe bottom surface to the top surface of manifold 240 for passingfeedthrough wires 232 to each respective distal housing-based electrode262. Each peripheral lumen 243 communicates with a horizontal,radially-extending channel 242 for guiding a respective feedthrough wire232 toward an electrical connection point with a respective housingbased electrode 262, e.g., toward a respective electrode cavity 74 ofinner body 70. Each channel 242 is shown to have a width that widensmoving toward the outer circumference 246 of manifold 240. The width 245of channel 242 near lumen 243 is less than the width 247 near outercircumference 246. The widening channel width moving toward the outercircumference 246 allows feedthrough wire(s) 232 to shift laterallywithin the distal fixation member and electrode assembly 36.

For example, feedthrough wires 232 may be threaded through electrodecavities 74 of inner body 70 during the assembly process describedabove. Inner body 70 assembled with outer ring 72 and fixation member220 is advanced over dart electrode 12 and seated on distal end cap 228then rotated to mechanically lock distal fixation member and electrodeassembly 36 in place as described in conjunction with FIG. 6. Duringrotation of inner body 70 and outer ring 72 relative to manifold 240 andhousing 30, lateral shifting of feedthrough wires 232 is accommodated bywidening channels 242. The gradual widening of channels 242 movingtoward outer circumference 246 avoids sharp bends or kinks in thefeedthrough wires 232 that may otherwise be caused during the rotation.

FIG. 14 is a block diagram of circuitry that may be enclosed withinhousing 30 to provide the functions of dual chamber pacing and sensingof pacemaker 10 according to one example. The electronic circuitryenclosed within housing 30 includes software, firmware and hardware thatcooperatively monitor atrial and ventricular electrical cardiac signals,determine when a pacing therapy is necessary, and deliver electricalpacing pulses to the patient's heart as needed according to programmedpacing mode and pacing pulse control parameters. The electroniccircuitry includes a control circuit 80, memory 82, therapy deliverycircuit 84, sensing circuit 86, and telemetry circuit 88. In someexamples, pacemaker 10 includes one or more sensors 90 for producing asignal that is correlated to a physiological function, state orcondition of the patient, such as a patient activity sensor, for use indetermining a need for pacing therapy and/or controlling a pacing rate.

A power source 98 provides power to the circuitry of pacemaker 10including each of the components 80, 82, 84, 86, 88 and 90 as needed.Power source 98 may include one or more energy storage devices, such asone or more rechargeable or non-rechargeable batteries. The connectionsbetween power source 98 and each of the other components 80, 82, 84, 86,88 and 90 are to be understood from the general block diagram of FIG.14, but are not shown for the sake of clarity. For example, power source98 is coupled to one or more charging circuits included in therapydelivery circuit 84 for providing the power needed to charge holdingcapacitors included in therapy delivery circuit 84 that are dischargedat appropriate times under the control of control circuit 80 fordelivering pacing pulses, e.g., according to a dual chamber pacing modesuch as DDI(R). Power source 98 is also coupled to components of sensingcircuit 86, such as sense amplifiers, analog-to-digital converters,switching circuitry, etc., sensors 90, telemetry circuit 88 and memory82 to provide power to the various circuits as needed.

The functional blocks shown in FIG. 14 represent functionality includedin pacemaker 10 and may include any discrete and/or integratedelectronic circuit components that implement analog and/or digitalcircuits capable of producing the functions attributed to dual chamberintracardiac pacemaker 10 herein. The various components may include anapplication specific integrated circuit (ASIC), an electronic circuit, aprocessor (shared, dedicated, or group) and memory that execute one ormore software or firmware programs, a combinational logic circuit, statemachine, or other suitable components or combinations of components thatprovide the described functionality. The particular form of software,hardware and/or firmware employed to implement the functionalitydisclosed herein will be determined primarily by the particular systemarchitecture employed in the pacemaker and by the particular detectionand therapy delivery methodologies employed by the pacemaker. Providingsoftware, hardware, and/or firmware to accomplish the describedfunctionality in the context of any modem cardiac medical device system,given the disclosure herein, is within the abilities of one of skill inthe art.

Memory 82 may include any volatile, non-volatile, magnetic, orelectrical non-transitory computer readable storage media, such asrandom access memory (RAM), read- only memory (ROM), non-volatile RAM(NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory,or any other memory device. Furthermore, memory 82 may includenon-transitory computer readable media storing instructions that, whenexecuted by one or more processing circuits, cause control circuit 80and/or other circuits to perform dual chamber pacing function or othersensing and therapy delivery functions attributed to pacemaker 10. Thenon-transitory computer-readable media storing the instructions mayinclude any of the media listed above.

Control circuit 80 communicates, e.g., via a data bus, with therapydelivery circuit 84 and sensing circuit 86 for sensing cardiacelectrical signals and controlling delivery of cardiac electricalstimulation therapies in response to sensed cardiac events, e.g.,P-waves and R-waves, or the absence thereof. Tip electrode 42, distalhousing-based electrode 22 (or 52, 62, or 262 as shown FIGS. 4, 5 and12A-C, respectively), and proximal housing- based electrode 24 areelectrically coupled to therapy delivery circuit 84 for deliveringelectrical stimulation pulses to the patient's heart and to sensingcircuit 86 and for sensing cardiac electrical signals.

Sensing circuit 86 includes an atrial (A) sensing channel 87 and aventricular (V) sensing channel 89. Distal housing-based electrode 22and proximal housing-based electrode 24 may be coupled to atrial sensingchannel 87 for sensing atrial signals, e.g., P-waves attendant to thedepolarization of the atrial myocardium In examples that include two ormore selectable distal housing-based electrodes, e.g., electrodes 62 a-cin FIG. 5 or electrodes 262 a-d in FIG. 12c , sensing circuit 86 mayinclude switching circuitry for selectively coupling one or more of theavailable distal housing-based electrodes to cardiac event detectioncircuitry included in atrial sensing channel 87. Switching circuitry mayinclude a switch array, switch matrix, multiplexer, or any other type ofswitching device suitable to selectively couple components of sensingcircuit 86 to selected electrodes. Tip electrode 42 and proximalhousing-based electrode 24 may be coupled to ventricular sensing channel89 for sensing ventricular signals, e.g., R-waves attendant to thedepolarization of the ventricular myocardium

Each of atrial sensing channel 87 and ventricular sensing channel 89include cardiac event detection circuitry for detecting P-waves andR-waves, respectively, from the cardiac electrical signals received bythe respective sensing channels. The cardiac event detection circuitryincluded in each channel 87 and 89 may be configured to amplify, filter,digitize and rectify the cardiac electrical signal received from theselected electrodes to improve the signal quality for detecting cardiacelectrical events. The cardiac event detection circuitry within eachchannel 87 and 89 may include one or more sense amplifiers, filters,rectifiers, threshold detectors, comparators, analog-to-digitalconverters (ADCs), timers or other analog or digital components. Acardiac event sensing threshold, e.g., a P-wave sensing threshold and anR-wave sensing threshold, may be automatically adjusted by eachrespective sensing channel 87 and 89 under the control of controlcircuit 80, e.g., based on timing intervals and sensing threshold valuesdetermined by control circuit 80, stored in memory 82, and/or controlledby hardware, firmware and/or software of control circuit 80 and/orsensing circuit 86.

Upon detecting a cardiac electrical event based on a sensing thresholdcrossing, sensing circuit 86 may produce a sensed event signal that ispassed to control circuit 80. For example, atrial sensing channel 87 mayproduce a P-wave sensed event signal in response to a P-wave sensingthreshold crossing. Ventricular sensing channel 89 may produce an R-wavesensed event signal in response to an R-wave sensing threshold crossing.The sensed event signals are used by control circuit 80 for settingpacing escape interval timers that control the basic time intervals usedfor scheduling cardiac pacing pulses. A sensed event signal may triggeror inhibit a pacing pulse depending on the particular programmed pacingmode. For example, a P-wave sensed event signal received from atrialsensing channel 87 may cause control circuit 80 to inhibit a scheduledatrial pacing pulse and schedule a ventricular pacing pulse at aprogrammed atrioventricular (AV) pacing interval. If an R-wave is sensedbefore the AV pacing interval expires, the ventricular pacing pulse isinhibited. If the AV pacing interval expires before control circuit 80receives an R-wave sensed event signal from ventricular sensing channel89, control circuit 80 controls therapy delivery circuit 84 to deliverthe scheduled ventricular pacing pulse synchronized to the sensedP-wave.

In some examples, pacemaker 10 may be configured to deliver a variety ofpacing therapies including bradycardia pacing, cardiac resynchronizationtherapy, post-shock pacing, and/or anti-tachycardia pacing. For example,pacemaker 10 may be configured to detect non-sinus tachycardia anddeliver ATP. Control circuit 80 may determine cardiac event timeintervals, e.g., PP intervals between consecutive P-wave sensed eventsignals received from atrial sensing channel 87, RR intervals betweenconsecutive R-wave sensed event signals received from ventricularsensing channel 89, and P-R and/or R-P intervals received between P-wavesensed event signals and R-wave sensed event signals. These intervalsmay be compared to tachycardia detection intervals for detectingnon-sinus tachycardia. Tachycardia may be detected in a given heartchamber based on a threshold number of tachycardia detection intervalsbeing detected.

Therapy delivery circuit 84 includes an atrial pacing circuit 83 and aventricular pacing circuit 85. Each pacing circuit 83 and 85 includescharging circuitry, one or more charge storage devices such as one ormore low voltage holding capacitors, an output capacitor, and switchingcircuitry that controls when the holding capacitor(s) are charged anddischarged across the output capacitor to deliver a pacing pulse to thepacing electrode vector coupled to the respective pacing circuit 83 or85. Tip electrode 42 and proximal housing-based electrode 24 may becoupled to ventricular pacing circuit 85 as a bipolar cathode and anodepair for delivering ventricular pacing pulses, e.g., upon expiration ofan AV or VV pacing interval set by control circuit 80 for providingatrial-synchronized ventricular pacing and a basic lower ventricularpacing rate.

Atrial pacing circuit 83 may be coupled to distal housing-basedelectrode 22 and proximal housing based electrode 24 to deliver atrialpacing pulses. Control circuit 80 may set atrial pacing intervalsaccording to a programmed lower pacing rate or a temporary lower rateset according to a rate-responsive sensor indicated pacing rate. Atrialpacing circuit is controlled to deliver an atrial pacing pulse if theatrial pacing interval expires before a P-wave sensed event signal isreceived from atrial sensing channel 87. Control circuit 80 starts an AVpacing interval in response to a delivered atrial pacing pulse toprovide synchronized dual chamber pacing.

Charging of a holding capacitor of atrial or ventricular pacing circuit83 or 85 to a programmed pacing voltage amplitude and discharging of thecapacitor for a programmed pacing pulse width may be performed bytherapy delivery circuit 84 according to control signals received fromcontrol circuit 80. For example, a pace timing circuit included incontrol circuit 80 may include programmable digital counters set by amicroprocessor of the control circuit 80 for controlling the basicpacing time intervals associated with various single chamber or dualchamber pacing modes or anti-tachycardia pacing sequences. Themicroprocessor of control circuit 80 may also set the amplitude, pulsewidth, polarity or other characteristics of the cardiac pacing pulses,which may be based on programmed values stored in memory 82.

Pacemaker 10 may include other sensors 90 for sensing signals from thepatient for use in determining a need for and/or controlling electricalstimulation therapies delivered by therapy delivery circuit 84. In someexamples, a sensor indicative of a need for increased cardiac output mayinclude a patient activity sensor, such as an accelerometer. An increasein the metabolic demand of the patient due to increased activity asindicated by the patient activity sensor may be determined by controlcircuit 80 for use in determining a sensor-indicated pacing rate.

Control parameters utilized by control circuit 80 for sensing cardiacevents, and controlling pacing therapy delivery may be programmed intomemory 82 via telemetry circuit 88. Telemetry circuit 88 includes atransceiver and antenna for communicating with an external device suchas a programmer or home monitor, using radio frequency communication orother communication protocols. Under the control of control circuit 80,telemetry circuit 88 may receive downlink telemetry from and send uplinktelemetry to the external device. In some cases, telemetry circuit 88may be used to transmit and receive communication signals to/fromanother medical device implanted in the patient.

FIG. 15 is a flow chart of a method for using the dual chamberintracardiac pacemaker 10. At block 402, the intracardiac pacemaker 10is mounted in a receptacle of a delivery tool, e.g., delivery tool 100shown in FIG. 9. As shown in FIG. 9, the fixation member 20 may be heldin an extended position within the receptacle. At block 404, the distalopening 110 of the delivery tool 100 is advanced to a desired implantsite, e.g., the target implant region 4 shown in FIG. 1. At the desiredimplant site, the fixation member is deployed by advancing the pacemaker10 out of the distal opening 110 of delivery tool 100, e.g., by anadvancement tool 104. As the fixation member is deployed at block 406,the dart electrode 12 is advanced into the cardiac tissue. As describedabove, the distal tip(s) of the fixation member and the distal tip ofthe dart electrode may enter the cardiac tissue simultaneously, the dartelectrode tip may enter first followed by the fixation member, or thefixation member may enter the tissue first followed by dart electrode12. If the dart electrode 12 has a greater height than the extendedfixation member, the dart electrode 12 may be advanced into the tissueby manual force applied by a clinician along a longitudinal axis of thepacemaker 10 transferred along the center longitudinal axis of shaft 40.

Deployment of the fixation member at block 406 produces a pulling forceas the fixation member engages the cardiac tissue, e.g., as elasticallydeformable tines are advanced into the tissue in a non-relaxed extendedposition and elastically bend or curve back to the normally curved,relaxed position. The pulling force may contribute to the longitudinalaxial force that causes advancement of the tip of the dart electrodeinto the cardiac tissue, e.g., the myocardium of an adjacent cardiacchamber which may be the ventricular myocardium when housing 30 islocated in an atrial chamber. As shown in FIG. 1, the tip electrode ofthe dart electrode may be advanced into the ventricular septum below theAV node and His bundle. After releasing the pacemaker 10 from thereceptacle, the delivery tool is removed from the patient at block 408.Pacemaker housing 30 remains wholly within one heart chamber, e.g., theright atrium, with dart electrode 12 extending into the myocardialtissue of a different heart chamber, e.g., the ventricular septum, toprovide pacing and sensing at two different sites, e.g., dual chamber,atrial-synchronized ventricular pacing.

FIG. 16 is a conceptual diagram of an intracardiac pacemaker 510 havingmore than one dart electrode. Pacemaker 510 includes a housing 530 andmay include at least one housing based electrode 524 as described inother examples presented herein. The distal fixation and electrodeassembly 536 includes fixation member 520, which may include one or moreelastically deformable tines as described above. In other examples, thefixation member of pacemaker 510 may include one or more helical tissueengaging portions extending along a peripheral path as shown in FIG. 11.

Distal fixation and electrode assembly 536 may include multiple dartelectrodes. Two dart electrodes 512 a and 512 b are shown in the exampleof FIG. 16, extending from inner body 570. Each dart electrode 512 a and512 b includes a straight shaft 540 a or 540 b extending distally frominner body 70 each having a respective distal tip electrode 542 a and542 b. In some examples, distal tip electrodes 542 a and 542 b areelectrically tied together to function as a dual cathode in polaritywith a housing-based electrode, e.g., electrode 524, serving as an anodefor pacing and/or sensing. In other examples, the tip electrodes 542 aand 542 b are each coupled to a separate, insulated conductor and may beselectable one at a time as a single cathode or in combination as a dualcathode. In still other examples, one of electrodes 542 a or 542 b maybe a cathode electrode and the other of electrodes 542 a and 542 b maybe an anode to provide bipolar pacing and/or sensing at the tissue depthwithin which tip electrodes 542 a and 542 b are implanted.

Each shaft 540 a and 540 b may include an electrical conductor extendingwithin a tubular body from the respective tip electrode 542 a and 542 bto a corresponding shaft receiving pin and/or electrical feedthroughwire that electrically couples the tip electrode 542 a or 542 b to thepacing and/or sensing circuitry enclosed by housing 530. As describedabove, each dart electrode 512 a and 512 b possesses compressivestrength to resist bending or flexing as tip electrodes 542 a and 542 bare advanced into cardiac tissue. Each shaft 540 a and 540 b may possesslateral flexibility to allow flexion with heart motion in response tolateral forces. While shafts 540 a and 540 b are shown having the samelength, it is contemplated that when two or more dart electrodes extendfrom distal fixation and electrode assembly 536, the length and/ordiameter of the shafts 540 a and 540 b and/or the size and shape of thecorresponding tip electrodes 542 and 542 b may be the same or different.

Pacemaker 510 may be a dual chamber intracardiac pacemaker having tipelectrodes 542 a and 542 b serving as a cathode and anode pair forsensing and/or pacing in ventricular tissue and a distal housing-basedcathode 552 paired with proximal housing- based anode 524 for pacing andsensing in the atrial chamber. In this example, housing- based cathode552 may include one or more button electrodes or a ring electrodecarried distal fixation and electrode assembly 536, as generallydescribed above.

FIG. 17 is a conceptual diagram of an intracardiac pacemaker 610 havingmore than one distal dart electrode 612 a and 612 b according to anotherexample. In this example, the two dart electrodes 612 a and 612 b extendfrom a separator 644 which may extend laterally, e.g., approximatelyorthogonal to the longitudinal axis of pacemaker 610. Separator 644 mayprovide a greater separation distance between tip electrodes 642 a and642 b than the separation distance between dart electrodes 512 a and 512b that extend straight out from the inner body 570 of distal fixationand electrode assembly 536. The separation distance of tip electrodes542 a and 542 b carried by dart electrodes 512 a and 512 b may belimited by the overall diameter of the distal fixation and electrodeassembly 536 when dart electrodes 512 a and 512 b each extend straightout from an opening defined by the inner body 570 of assembly 536.Separator 644 may extend outward from a central base 646 that couplesthe separator 644 (and associated electrical conductors extending therethrough) to the housing 630.

The shafts 640 a and 640 b may each be straight, linear shafts separatedby a distance 650 (corresponding to the length of separator 644) thatmay be equal to or greater than the diameter of inner body 670 or evenequal to or greater than the diameter of pacemaker housing 630. In thisexample, shaft 640 b is shown having a shorter length than shaft 640 a,though both shafts may have the same length in other examples. Pacemaker610 may be a dual chamber intracardiac pacemaker having electrodes 642 aand 642 b serving as a cathode and anode pair for sensing and/or pacingin ventricular tissue and a distal housing-based cathode 652, shown as aring electrode circumscribing distal fixation and electrode assembly636, paired with proximal housing-based anode 624 for pacing and sensingin the atrial chamber when fixation member 620 anchors housing 630 in anatrial chamber. As such, in various embodiments, an intracardiacpacemaker may include one or more dart electrodes extending from adistal end of the pacemaker to provide one or more tip electrodespositioned at a pacing or sensing site within the cardiac tissue, e.g.,in the myocardium of a heart chamber that is adjacent to the heartchamber in which the pacemaker housing is implanted.

FIG. 18 is a three dimensional perspective view of a leadlessintracardiac pacemaker 710 configured for dual chamber cardiac pacingaccording to yet another example. Pacemaker 710 includes a housing 730having an outer sidewall 735, shown as a cylindrical outer sidewall,extending from a housing distal end 732 to a housing proximal end 734.Housing 730 encloses electronic circuitry configured to perform atrialand ventricular cardiac electrical signal sensing and for deliveringdual chamber pacing to the atrial and ventricular chambers as needed,e.g., as described above in conjunction with FIG. 14. A delivery toolinterface member 726 is shown on the housing proximal end 734.

A distal fixation and electrode assembly 736 is coupled to the housingdistal end 732. Distal fixation and electrode assembly 736 may includean electrically insulative distal member 772 coupled to housing distalend 732. A tissue piercing electrode 712 extends away from housingdistal end 732, and multiple non-tissue piercing electrodes 722 arecoupled directly to insulative distal member 772. The tissue piercingelectrode 712 extends in a longitudinal direction away from housingdistal end 732 and may be coaxial with the longitudinal center axis 731of housing 730.

Tissue piercing distal electrode 712 includes an electrically insulatedshaft 740 and a tip electrode 742. In some examples, tissue piercingdistal electrode 712 is an active fixation member including a helicalshaft 740 and a distal cathode tip electrode 742. The helical shaft 740extends from a shaft distal end 743 to a shaft proximal end 741 that isdirectly coupled to insulative distal member 772. Helical shaft 740 maybe coated with an electrically insulating material, e.g., parylene orother examples listed herein, to avoid sensing or stimulation of cardiactissue along the shaft length. Tip electrode 742 is at the shaft distalend 743 and may serve as a cathode electrode for delivering ventricularpacing pulses and sensing ventricular electrical signals using proximalhousing based electrode 724 as a return anode when the tip electrode 742is advanced into ventricular tissue. Proximal housing based electrode724 may be a ring electrode circumscribing housing 730 and may bedefined by an uninsulated portion of longitudinal sidewall 724. Otherportions of housing 730 not serving as an electrode may be coated withan electrically insulating material as described above in conjunctionwith FIG. 2.

Multiple non-tissue piercing electrodes 722 are provided along aperiphery of insulative distal member 772, peripheral to tissue piercingelectrode 712. Insulative distal member 772 defines a distal-facingsurface 738 of pacemaker 710 and a circumferential surface 739 thatcircumscribes pacemaker 710 adjacent to housing longitudinal sidewall735. Non-tissue piercing electrodes 722 may be formed of an electricallyconductive material, such as titanium, platinum, iridium or alloysthereof. In FIG. 18, six non-tissue piercing electrodes 722 are spacedapart radially at equal distances along the outer periphery ofinsulative distal member 772, however two or more non-tissue piercingelectrodes 722 may be provided.

Non-tissue piercing electrodes 722 may be discrete components eachretained within a respective recess 774 in insulative member 772 that issized and shaped to mate with a non-tissue piercing electrode 722. Inother examples, non-tissue piercing electrodes 722 may each be anuninsulated, exposed portion of a unitary member mounted within or oninsulative distal member 772. Intervening portions of the unitary membernot functioning as an electrode may be insulated by insulative distalmember 772 or, if exposed to the surrounding environment, coated with anelectrically insulating coating, e.g., parylene, polyurethane, silicone,epoxy, or other insulating coating.

When tissue piercing electrode 712 is advanced into cardiac tissue, atleast one of the non-tissue piercing electrodes 722 is positionedagainst, in intimate contact with or in operative proximity to, acardiac tissue surface for delivering pacing pulses and/or sensingcardiac electrical signals produced by the patient's heart. For example,non-tissue piercing electrodes 722 may be positioned in contact withright atrial endocardial tissue for pacing and sensing in the atriumwhen tissue piercing electrode 712 is advanced into the atrial tissueand through the central fibrous body until distal tip electrode 742 ispositioned in direct contact with ventricular tissue, e.g., ventricularmyocardium and/or a portion of the ventricular conduction system

Non-tissue piercing electrodes 722 may be coupled to the therapydelivery circuit 84 and sensing circuit 86 enclosed by housing 730 tofunction collectively as a cathode electrode for delivering atrialpacing pulses and for sensing atrial electrical signals, e.g., P-waves,in combination with the proximal housing-based electrode 724 as a returnanode. Switching circuitry included in sensing circuit 86 may beactivated under the control of control circuit 80 to couple one or moreof the non-tissue piercing electrodes to atrial sensing channel 87. Thedistal, non-tissue piercing electrodes 722 may be electrically isolatedfrom each other so that each individual one of electrodes 722 may beindividually selected by switching circuitry included in therapydelivery circuit 84 to serve alone or in a combination of two or more ofelectrodes 722 as an atrial cathode electrode. Switching circuitryincluded in therapy delivery circuit 84 may be activated under thecontrol of control circuit 80 to couple one or more of the non-tissuepiercing electrodes 722 to atrial pacing circuit 83. Two or more of thenon-tissue piercing electrodes 722 may be selected at a time to operateas a multi-point atrial cathode electrode.

The particular ones of the non-tissue piercing electrodes 722 selectedfor atrial pacing and/or atrial sensing may be selected based on atrialcapture threshold tests, electrode impedance, P-wave signal strength inthe cardiac electrical signal, or other factors. For example, a singleone or any combination of two or more individual non- tissue piercingelectrodes 722 functioning as a cathode electrode that provides anoptimal combination of a low pacing capture threshold amplitude andrelatively high electrode impedance may be selected to achieve reliableatrial pacing using minimal current drain from power source 98.

In some instances, the distal-facing surface 738 may uniformly contactthe atrial endocardial surface when tissue piercing electrode 712anchors the housing 730 at an implant site. In that case, all ofelectrodes 722 may be selected together to form the atrial cathode.Alternatively, every other one of electrodes 722 may be selectedtogether to form a multi-point atrial cathode having a higher electricalimpedance that is still uniformly distributed along the distal-facingsurface 738. Alternatively, a subset of one or more electrodes 722 alongone side of insulative distal member 772 may be selected to providepacing at a desired site that achieves the lowest pacing capturethreshold due to the relative location of electrodes 722 to the atrialtissue being paced.

In other instances, the distal-facing surface 738 may be oriented at anangle relative to the adjacent endocardial surface depending on thepositioning and orientation at which the tissue piercing electrode 712enters the cardiac tissue. In this situation, one or more of thenon-tissue piercing electrodes 722 may be positioned in closer contactwith the adjacent endocardial tissue than the other non-tissue piercingelectrodes 722, which may be angled away from the endocardial surface.By providing multiple non-tissue piercing electrodes along the peripheryof the insulative distal member 772, the angle of tissue piercingelectrode 712 and housing distal end 732 relative to the cardiacsurface, e.g., the right atrial endocardial surface, is not required tobe substantially parallel. Anatomical and positional differences maycause the distal-facing surface 738 to be angled or oblique to theendocardial surface, however, the multiple non-tissue piercingelectrodes 722 distributed along the periphery of insulative distalmember 772 increase the likelihood of good contact between one or moreelectrodes 722 and the adjacent cardiac tissue to promote acceptablepacing thresholds and reliable cardiac event sensing using at least asubset of the multiple electrodes 722. Contact or fixationcircumferentially along the entire periphery of the insulative distalmember 772 is not required.

The non-tissue piercing electrodes 722 are shown to each include a firstportion 722 a extending along the distal-facing surface 738 and a secondportion 722 b extending along the circumferential surface 739. The firstportion 722 a and second portion 722 b may be continuous exposedsurfaces such that the active electrode surface wraps around theperipheral edge 776 of insulative distal member 772 that joins thedistal facing surface 738 and circumferential surface 739. Thenon-tissue piercing electrodes 722 may include one or more of electrodes772 along distal-facing surface 738, one or more along circumferentialsurface 739, one or more electrodes each extending along both of thedistal-facing surface 738 and the circumferential surface 739, or anycombination thereof. The exposed surface of each of the non-tissuepiercing electrodes 722 may be flush with the respective distal-facingsurface 738 and/or circumferential surface. In other examples, each ofnon-tissue piercing electrodes 722 may have a raised surface thatprotrudes from insulative distal member 772. Any raised surface ofelectrodes 722, however is a smooth or rounded, non-tissue piercingsurface.

Since distal fixation and electrode assembly 736 seals the distal end ofhousing 730 and provides a foundation on which the electrodes 722 aremounted, the electrodes 722 may be referred to as housing-basedelectrodes. These electrodes 722 are not carried by a shaft or otherextension that extends the active electrode portion away from thehousing 730, like distal tip electrode 742 residing at the distal tip ofhelical shaft 740 extending away from housing 730. Other examples ofnon-tissue piercing electrodes presented herein that are coupled to adistal-facing surface and/or a circumferential surface of an insulativedistal member include distal housing based ring electrode 22 (FIG. 3),distal housing based ring electrode 52 extending circumferentiallyaround assembly 36 (FIG. 4), button electrodes 62 a-c (FIG. 5), buttonelectrodes 262 (FIG. 12C), housing based electrode 552 (FIG. 16) andcircumferential ring electrode 652 (FIG. 17). Any of these non-tissuepiercing electrodes directly coupled to a distal insulative member,peripherally to a central tissue-piercing electrode, may be provided tofunctioning individually, collectively, or in any combination as acathode electrode for delivering pacing pulses to adjacent cardiactissue. When a ring electrode, such as distal ring electrode 22 and/orcircumferential ring electrode 52 is provided, portions of the ringelectrode may be electrically insulated by a coating to provide multipledistributed non-tissue piercing electrodes along the distal- facingsurface and/or the circumferential surface of the insulative distalmember.

The non-tissue piercing electrodes 722 and other examples listed aboveare expected to provide more reliable and effective atrial pacing andsensing than a tissue piercing electrode provided along distal fixationand electrode assembly 736. The atrial chamber walls are relatively thincompared to ventricular chamber walls. A tissue piercing atrial cathodeelectrode may extend too deep within the atrial tissue leading toinadvertent sustained or intermittent capture of ventricular tissue. Atissue piercing atrial cathode electrode may lead to interference withsensing atrial signals due to ventricular signals having a larger signalstrength in the cardiac electrical signal received via tissue-piercingatrial cathode electrodes that are in closer physical proximity to theventricular tissue. The tissue piercing electrode 712 may be securelyanchored into ventricular tissue stabilizing the implant position ofpacemaker 710 and providing reasonable certainty that tip electrode 742is sensing and pacing in ventricular tissue while the non-tissuepiercing electrodes 722 are reliably pacing and sensing in the atriumWhen pacemaker 710 is implanted in the target implant region 4, e.g., asshown in FIG. 1, the tip electrode 742 may reach left ventricular tissuefor pacing of the left ventricle while non-tissue piercing electrodes722 provide pacing and sensing in the right atrium Tissue piercingelectrode 712 may be in the range of 4 mm to 8 mm in length fromdistal-facing surface 738 to reach left ventricular tissue. In someinstances, pacemaker 710 may achieve four chamber pacing by deliveringatrial pacing pulses from atrial pacing circuit 83 via the non-tissuepiercing electrodes 722 in the target implant region 4 to achievehi-atrial (right and left atrial) capture and by delivering ventricularpacing pulses from ventricular pacing circuit 85 via tip electrode 742advanced into ventricular tissue from target implant region 4 to achievebiventricular (right and left ventricular) capture.

FIG. 19 is a top schematic view of a unitary member 720 including acontinuous ring 728 along which electrodes 722 are mounted. Unitarymember 720 may be a machined component formed from a conductive metal.In other examples, unitary member 720 may be an assembly of multipleparts in which electrodes 722 are mechanically coupled to ring 728, forexample by welding or adhesively coupling. Ring 728 may define anaperture 729 through which one or more electrically conductivefeedthrough wires may extend for electrically coupling unitary member(and thus all of electrodes 722) to circuitry within pacemaker 710.Aperture 729 is shown as an elongated aperture to allow unitary member720 and insulative distal member 772 to be rotatably coupled to housing730 when electrically conductive feedthrough wires extend throughaperture 729.

FIG. 20 is a three dimensional, exploded view of the distal fixation andelectrode assembly 736 of pacemaker 710. Insulative distal member 772may be overmolded onto unitary member 720 such that non-tissue piercingelectrodes 722 are exposed at each recess 774. Insulative distal member772 may include radially-extending tabs 780 for interlocking withretaining tabs 784 of a distal end cap 782 of housing 730. Radially-extending tabs 780 may be aligned with notches 786 of distal end cap 782to place insulative distal member 772 against distal end cap 782.Insulative distal member 772 may be rotated so that radially-extendingtabs 780 are captured beneath retaining tabs 784 of distal end cap 782.

A central feedthrough wire 790 extends through distal end cap 782 andinsulative distal member 772 to be electrically coupled to tissuepiercing electrode 712, e.g., via an electrically conductive coupler794. The tissue-piercing electrode 712 may be mounted on coupler 794such that shank 740 is electrically coupled to feedthrough wire 790 viacoupler 794. One or more peripheral feedthrough wires 792 extend throughdistal end cap 782 and the aperture 729 (FIG. 19) for electricalconnection to non-tissue piercing electrodes 722. A single peripheralfeedthrough wire 792 may be electrically coupled to a unitary member(e.g., member 720 of FIG. 19) that carries all of and is electricallycoupled to electrodes 722. In examples that include individuallyselectable electrodes, multiple peripheral feedthrough wires extendingthrough a single aperture or multiple apertures may be electricallycoupled to respective electrodes 722. After the distal fixation andelectrode assembly 736 is assembled onto distal end cap 782 andnecessary electrical connections have been made, a medical adhesive maybe applied to hermetically seal and protect the electrical connections.The example of FIG. 20 represents one method of assembling multiplenon-tissue piercing electrodes peripheral to a central tissue piercingelectrode at the distal end of pacemaker housing 730. It is recognizedthat other assembly methods may be used to provide multiple non-tissuepiercing electrodes along the distal- facing surface 738 and/orcircumferential surface 739.

FIG. 21 is a conceptual diagram of the atrial sensing channel 87 ofsensing circuit 86 and atrial pacing circuit 83 of therapy deliverycircuit 84 (shown in FIG. 14) coupled to the multiple electrodes 722 viaswitching circuitry 750 and 752. The sensing circuit 86 may includemultiple switches 750 a-n, collectively 750, that may be controlled bysensing circuit 86 in response to control signals received from controlcircuit 80. Sensing circuit 86 opens and closes switches 750 a-n atappropriate times for electrically coupling respective electrodes 722a-n to atrial sensing channel 87, one or more at a time. One, two, threeor more, up to all n electrodes 722 a-n, may be switchably coupled toatrial sensing channel 87 at a time to function as a single ormulti-point cathode electrode for sensing atrial signals in combinationwith housing-based anode electrode 724.

Therapy delivery circuit 84 includes multiple switches 752 a-n,collectively switches 752, for selectively coupling electrodes 722 a-nto atrial pacing circuit 83 in any desired combination. One, two, threeor more, up to all n electrodes 722 a-n, may be electrically coupled toatrial pacing circuit 83 via switches 752 a-n for functioning as asingle or multi-point cathode electrode for delivering atrial pacingpulses. Control circuit 80 may be configured to control therapy deliverycircuit 84 to select one or a combination of two or more electrodes 722a-n to serve as the atrial pacing cathode.

Electrodes 722 a-n may include six non-tissue piercing electrodesperipheral to the tissue piercing electrode 712, as shown in FIG. 18,but may include fewer than six electrodes or more than six electrodes inother examples. In any of the examples presented herein that includemultiple, non-tissue piercing electrodes along a distal-facing and/orcircumferential surface of the distal fixation and electrode assembly,each of the non-tissue piercing electrodes may be electrically isolatedfrom one another and coupled to electrically isolated conductors thatcouple each non-tissue piercing electrode to the atrial sensing channel87 and/or the atrial pacing circuit 83 via the respective switches 750a-n and 752 a-n.

FIG. 22 is a three-dimensional view of a pacemaker 810 according toanother example. Pacemaker 810 includes a housing 830 having acylindrical longitudinal sidewall 835 extending from a housing proximalend 834 to a housing distal end 832. A delivery tool interface member826 may extend from the housing proximal end 834 as described previouslyherein. A distal fixation and electrode assembly 836 is coupled directlyto the housing distal end 832.

Distal fixation and electrode assembly 836 includes an insulative member872 having a distal-facing surface 838, a tissue piercing distalelectrode 812, and a non-tissue piercing distal electrode 822. Tissuepiercing distal electrode 812 extends in a longitudinal direction awayfrom housing distal end 832 and may be coaxial with the longitudinalcenter axis 831 of housing 830. Tissue piercing distal electrode 812includes an electrically insulated shaft 840 and a tip electrode 842. Inthis example, tissue piercing distal electrode 812 is an active fixationmember including a helical shaft 840 and a distal tip electrode 842which may function as a cathode electrode for pacing and sensing in aheart chamber adjacent to the chamber in which pacemaker 810 isimplanted. For example, when the tip electrode 842 is advanced intoventricular tissue and housing 830 is implanted in the right atrium, tipelectrode 842 may serve as a cathode electrode for deliveringventricular pacing pulses and sensing ventricular electrical signalsusing proximal housing based electrode 824 as a return anode.

Tissue piercing distal electrode 812 is peripheral to non-tissuepiercing electrode 822 on distal-facing surface 838. Non-tissue piercingelectrode 822 may be, for example, a button or hemispherical electrodethat protrudes from a central portion of distal-facing surface 838 andis circumscribed or encircled by, but spaced apart and electricallyisolated from, helical shaft 840 of tissue piercing distal electrode812. In some examples, non- tissue piercing electrode 822 includes acoating or is a steroid eluting electrode. For example, non-tissuepiercing electrode 822 may be a ring electrode defining a centralopening or may include a recess or concavity for retaining an MCRDincluding a polymer matrix, e.g., a silicone or polyurethane base, and asteroid, e.g., sodium dexamethasone phosphate, compounded in the polymermatrix for eluting over time to reduce the foreign body response at theimplant site. Both non-tissue piercing distal electrode 822 and helicalshaft 840 may be centered along the longitudinal center axis of housing830 in some examples with helical shaft 840 winding around and centeredon non-tissue piercing distal electrode 822.

When tissue piercing distal electrode 812 is fully advanced from theright atrium into direct contact with the ventricular myocardial orconductive tissue, the non-tissue piercing distal electrode 822 isanchored against or in operative proximity to atrial tissue. The activefixation of housing 830 in the atrial chamber by tissue piercing distalelectrode 812 maintains the position of tip electrode 842 forventricular sensing and pacing and the position of non-tissue piercingdistal electrode 822 for atrial pacing and sensing for providing dualchamber pacing. Non-tissue piercing distal electrode 822 may function asan atrial cathode electrode for pacing the right atrium and sensingatrial signals in combination with proximal housing-based electrode 824serving as the anode.

Thus, a pacemaker has been presented in the foregoing description withreference to specific embodiments. It is to be understood that variousaspects disclosed herein may be combined in different combinations thanthe specific combinations presented in the accompanying drawings. It isappreciated that various modifications to the referenced embodiments maybe made without departing from the scope of the disclosure and thefollowing claims.

What is claimed is:
 1. A pacemaker comprising: a housing having a proximal end, a distal end and a longitudinal sidewall extending from the proximal end to the distal end; a therapy delivery circuit enclosed by the housing configured to generate pacing pulses for delivery to a patient's heart; an anode electrode defined by an electrically conductive portion of the housing; an electrically insulative distal member coupled to the housing distal end; at least one non-tissue piercing cathode electrode coupled directly to the insulative distal member and electrically coupled to the therapy delivery circuit for delivering a first portion of the generated pacing pulses via a first pacing electrode vector including the at least one non-tissue piercing cathode electrode and the anode electrode; and a tissue piercing electrode extending away from the housing distal end for delivering a second portion of the generated pacing pulses, wherein the pacemaker is configured to implant within a chamber of a heart, and wherein the tissue piercing electrode is configured to deliver pacing pulses to the ventricular conduction system of the heart when the pacemaker implants within the chamber of the heart.
 2. The pacemaker of claim 1, wherein the tissue piercing electrode is configured to deliver the second portion of the generated pacing pulses to at least one of a Bundle of His of the heart, bundle branches of the heart, or Purkinje fibers of the heart when the tissue piercing electrode delivers pacing pulses to the ventricular conduction system.
 3. The pacemaker of claim 1, wherein the tissue piercing electrode is configured to position in contact with a portion of the ventricular conduction system of the heart when the pacemaker implants within the chamber of the heart.
 4. The pacemaker of claim 3, wherein the tissue piercing electrode is configured to position in contact with at least one of a Bundle of His of the heart, bundle branches of the heart, or Purkinje fibers of the heart when the tissue piercing electrode positions in contact with the portion of the ventricular conduction system.
 5. The pacemaker of claim 1, wherein the pacemaker is configured to implant within a right atrium of the heart.
 6. The pacemaker of claim 1, wherein the pacemaker is configured to implant in a target implant region between a Bundle of His of the heart and a coronary sinus of the heart.
 7. The pacemaker of claim 1, further comprising: a sensing circuit enclosed by the housing; an atrial sensing channel electrically coupled to the non-tissue piercing cathode electrode, wherein the atrial sensing channel is configured to receive a first cardiac electrical signal of the patient's heart and communicate a signal indicative of the first cardiac electrical signal to the sensing circuit for detection of atrial depolarizations; and a ventricular sensing channel electrically coupled to the tissue piercing electrode, wherein the ventricular sensing channel is configured to receive a second cardiac electrical signal of the patient's heart and communicate a signal indicative of the second cardiac electrical signal to the sensing circuit for detection of ventricular depolarizations.
 8. The pacemaker of claim 7, wherein the ventricular sensing channel is configured to receive the second cardiac electrical signal from the ventricular conduction system and communicate a signal indicative of the second cardiac electrical signal to the sensing circuit for detection of ventricular depolarizations.
 9. The pacemaker of claim 7, wherein: the first cardiac electrical signal is a P-wave of the patient's heart and the atrial sensing channel includes first cardiac event detection circuitry configured to detect the P-wave, and the second cardiac electrical signal is an R-wave of the patient's heart and the ventricular sensing channel includes second cardiac event detection circuitry configured to detect the R-wave.
 10. The pacemaker of claim 9, wherein: the atrial sensing channel is configured to determine when the P-wave crosses a P-wave sensing threshold and communicate the signal indicative of the first cardiac electrical signal when the P-wave crosses the P-wave sensing threshold, and the ventricular sensing channel is configured to determine when the R-wave crosses an R-wave sensing threshold and communicate the signal indicative of the second cardiac electrical signal when the R-wave crosses the R-wave sensing threshold.
 11. The pacemaker of claim 1, wherein the tissue piercing electrode is configured to deliver the second portion of the generated pacing pulses via a second pacing electrode vector including the tissue piercing electrode and at least one of the anode electrode or the at least one non-tissue piercing electrode.
 12. The pacemaker of claim 1, wherein the at least one non-tissue piercing cathode electrode comprises a plurality of non-tissue piercing electrodes coupled directly to a periphery of the insulative distal member.
 13. The pacemaker of claim 12, further comprising: a plurality of electrical conductors, wherein each individual conductor in the plurality of electrical conductors is configured to couple an individual non-tissue piercing electrode in the plurality of non-tissue piercing electrodes to the therapy delivery circuit, switching circuitry configured to cause the each individual conductor to couple the individual non-tissue piercing electrode to the therapy delivery circuit for delivery of the first portion of the generated pacing pulses.
 14. The pacemaker of claim 1, further comprising a fixation member configured to anchor the distal end of the pacemaker in a target implant region in the chamber of the heart.
 15. The pacemaker of claim 14, wherein the fixation member is an active fixation member comprising an electrically insulated shaft extending from a proximal shaft end coupled to the housing distal end to a distal shaft end, wherein the electrically insulated shaft supports the tissue piercing electrode.
 16. A pacemaker comprising: a housing having a proximal end, a distal end and a longitudinal sidewall extending from the proximal end to the distal end; a therapy delivery circuit enclosed by the housing for generating pacing pulses for delivery to a patient's heart; an anode electrode defined by an electrically conductive portion of the housing; an electrically insulative distal member coupled to the housing distal end; at least one non-tissue piercing cathode electrode coupled directly to the insulative distal member and electrically coupled to the therapy delivery circuit for delivering a first portion of the generated pacing pulses via a first pacing electrode vector including the at least one non-tissue piercing cathode electrode and the anode electrode; a tissue piercing electrode extending away from the housing distal end for delivering a second portion of the generated pacing pulses; and a fixation member configured to anchor the distal end of the pacemaker in a target implant region in the chamber of the heart, wherein the pacemaker is configured to implant within a chamber of a heart, and wherein the tissue piercing electrode is configured to deliver pacing pulses to at least one of a Bundle of His of the heart, bundle branches of the heart, or Purkinje fibers of the heart when the pacemaker implants within the chamber of the heart.
 17. The pacemaker of claim 16, further comprising: a sensing circuit enclosed by the housing; an atrial sensing channel electrically coupled to the non-tissue piercing cathode electrode, wherein the atrial sensing channel is configured to receive a first cardiac electrical signal of the patient's heart and communicate a signal indicative of the first cardiac electrical signal to the sensing circuit for detection of atrial depolarizations; and a ventricular sensing channel electrically coupled to the tissue piercing electrode, wherein the ventricular sensing channel is configured to receive a second cardiac electrical signal of the patient's heart and communicate a signal indicative of the second cardiac electrical signal to the sensing circuit for detection of ventricular depolarizations.
 18. The pacemaker of claim 16, wherein the at least one non-tissue piercing cathode electrode comprises a plurality of non-tissue piercing electrodes coupled directly to a periphery of the insulative distal member.
 19. A method, comprising: delivering a first portion of generated pacing pulses via a first pacing electrode vector using at least one non-tissue piercing cathode electrode and an anode electrode, wherein the at least one non-tissue piercing cathode electrode is electrically coupled to a therapy delivery circuit configured to generate the pacing pulses for delivery to a patient's heart, wherein the non-tissue piercing electrode is coupled directly to an insulative distal member coupled to a distal end of a housing having a proximal end, the distal end and a longitudinal sidewall extending from the proximal end to the distal end, wherein the therapy delivery circuit is enclosed by the housing, and wherein the anode electrode is defined by an electrically conductive portion of the housing; and delivering a second portion of the generated pacing pulses using a tissue piercing electrode extending away from the housing distal end, herein the pacemaker is configured to implant within a chamber of a heart, wherein the tissue piercing electrode is configured to deliver pacing pulses to the ventricular conduction system of the heart when the pacemaker implants within the chamber of the heart.
 20. The method of claim 19, further comprising delivering the second portion of the generated pacing pulses to at least one of a Bundle of His of the heart, bundle branches of the heart, or Purkinje fibers of the heart when the tissue piercing electrode delivers pacing pulses to the ventricular conduction system. 